POSITION: Assistant Director of Clinical Research
RESPONSIBLE TO: Associate Medical Director of Clinical Research, Chief Medical Officer
JOB SUMMARY: Under the direction of the Associate Medical Director of Clinical Research and Chief Medical Officer, the Assistant Director of Clinical Research is responsible for developing and supporting a centralized clinical research program.
Responsibilities include, but are not limited to, the following: duties will be performed in coordination with the Associate Medical Director as appropriate.
- Develop a centralized electronic document management system for storage and monitoring of trial-related documents: regulatory documents, research staff licenses, CV’s, training certificates, etc.
- Develop standard operating procedures (SOPs) for document submission, storage, and management.
- Implement an electronic Clinical Trial Management System.
- Initial assessment and compilation of current research sites’ SOPs and best practices for the development of system-wide SOPs and research practices.
- Develop SOPs to implement across research sites.
- Develop a training curriculum for both existing and new research staff.
- Develop a template and standardization for centralized study budgeting.
- Develop a standardized research protocol evaluation template.
- Develop a centralized patient recruitment program.
- In coordination with in-house Counsel, develop a template for contract assessment.
- Establish and maintain up-to-date inventory of research related equipment across research sites.
- Establish and maintain a schedule for routine inspection and certification of research equipment.
- Coordinate with appropriate Allergy Partners departments for centralized purchasing of research equipment and supplies.
- Develop a mechanism for centralized billing and collections for research activities.
- Implement a centralized study participant payment system.
- Establish training requirements for study site participation: GCP, research ethics, etc.
- Maintain any required certifications, i.e., GCP training.
- Compile and maintain all relevant federal, state, and local guidelines with regard to clinical trials.
- Maintain patient confidentiality and comply with HIPAA and compliance guidelines as established by the practice.
- Maintain research-related knowledge of practice management and other computer software.
- Maintain personal OSHA, HIPPA, and OIG certifications.
Supervisory Responsibilities
- Central research staff as appropriate.
Typical Physical Demands
Position requires the full range of body motion including manual and finger dexterity and eye-hand coordination. Involves standing and walking. Employee will occasionally be asked to lift and carry items weighing up to 30 pounds. Normal visual acuity and hearing are required. Employee may work under stressful conditions and is expected to handle multiple demands and competing deadlines.
Typical Working Condition
Normal office environment. Occasional evening and weekend.
